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Our Mission

Alzheimer's disease is a very difficult disease to treat, and the field is crowded with companies hoping to see success with their treatments.
Pentara Corporation specializes in Alzheimer's disease clinical study design and efficacy analysis with at least 95% of Pentara's business devoted to the planning and implementation of efficacy analyses in Alzheimer's disease.
The reason for this highly specialized approach is that Pentara is a small company, and the field of Alzheimer's disease is progressing rapidly in terms of measurement of disease, population selection and efficacy analysis.
In order to be the very best at what we do, we have restricted ourselves to a field in which we can be on the cutting edge and offer our customers the reassurance that at the end of their clinical trial
-- whether it fails or succeeds --
they don't have to question whether they have measured the right outcomes and analyzed them in the best way.

We want them to be able to present results to outside audiences in a compelling way in order to move forward with confidence that decisions have been based on solid scientific evidence.

Our Services

Pentara has two different business arrangements that suit the needs of their clients in the Alzheimer's disease field. The first is an arrangement where the primary service performed by Pentara is improving the planning of the clinical trial by optimizing the population selection, the efficacy outcome measurement and calculation, and the statistical analysis of the efficacy outcome. This arrangement is appropriate when a company has experience in Alzheimer's disease, but wants to venture into a new population, consider a new outcome, or improve the analysis methods in order to be more confident that the study design being planned is customized to the new project being considered. In most of these cases, the company is performing their own statistical analyses, programming their own tables, figures and listings, and has a staff that are either already experienced with Alzheimer's disease, or ready to become experienced as part of a long term commitment to this field. Often, these types of arrangements lead to publications or presentations of the results in order to share the insights learned with the field.

The second type of arrangement is one where the primary service performed by Pentara is the production of efficacy tables, and figures. This arrangement is more appropriate when a company is new to Alzheimer's disease and is performing a study in a population that is already well-studied with an outcome that is standard. Pentara has standard tables and figures that reflect the best approaches currently used in the Alzheimer's disease field. As the field progresses, these standard tables and figures are updated to reflect current thinking. The analyses in this case are likely to be traditional, with some updating, and Pentara would assist in writing the analyses into the protocol (along with calculation of the sample size) and the statistical analysis plan. In this case, the production of all of the tables, figures and listings can be performed by Pentara Corporation, but it is important that the efficacy analyses are performed by Pentara*. A combination of the two approaches may be desired, particularly in the case when the company is interested in optimizing the analysis or the outcomes for the specific study being planned, but when most of the aspects of the study design are standard.
*In the past, Pentara has offered the option of writing the protocol statistical section and the efficacy analysis section of the statistical analysis plan in cases when all analyses -- efficacy and non-efficacy -- are being performed by an outside group, but this has not proven to be in the best interest of our clients. In some cases, the outside companies performing the analyses have not performed them in the intended way, or have made decisions about the details of the analysis that were not consistent with the plan and the result was that the company was unsure whether the inconsistencies in the results were due to lack of a treatment effect or due to the decisions made during the analysis process.

Publications

Hendrix SB: Measuring clinical progression in MCI and pre-MCI populations: Time as the Gold Standard. Commisioned review article currently under review, Alzheimer’s Research & Therapy 2012

Hendrix SB: Requiring an amyloid-β1–42 biomarker may improve the efficiency of a study, and simulations may help in planning studies. Alzheimer’s Research & Therapy 2011, 3:X.

Job Opportunities

Pentara is always interested in connecting with SAS programmers and Statisticians that want to be in the Salt Lake Area.
If you have at least 3 years of clinical trial programming experience in SAS, and you are interested in part-time programming work (remote), please contact us.
Statisticians please contact Suzanne Hendrix (shendrix at pentaracorp dot com).
SAS Programmers please contact Kent Hendrix (khendrix at pentaracorp dot com). 801-699-4295

Software Architect

Job Description

The Software Architect will act as team leader / lead developer to oversee a group of developers to create a suite of web applications to help small to mid-sized companies, and universities collect, manage, standardize, and interpret clinical trial data.

Qualifications and/or Preferred Skills

Team Leadership Skills

Excellent Communication Skills

Egalitarian life philosophy

Must be familiar with Visual Stuido

ASP.NET

C#

SQL, SQL Server Stored proc & functions

HTML 5

JavaScript

AJAX

jQuery

css

Software Testing

Git

ASP.NET Developer

Job Description

The ASP.NET developer will work in close conjunction with the web designer to create a sleek yet functional user interface for a clinical trial management system, and supporting modules, designed to scale to a variety of platforms from mobile devices to desktops.

Qualifications and/or Preferred Skills

Must be familiar with Visual Stuido

ASP.NET

C#

HTML 5

JavaScript

AJAX

jQuery

css

Code documentation

Git

Web Designer

Job Description

The Web Designer will work to make the suite of web applications we are developing have a spectacular user interface. You’ll make sure that the flow of the web site is clear, and looks good on a wide variety of devices, desk tops, and browsers. You’ll make sure that the graphics and icons are clean, and speak to the functionality they represent.

Qualifications and/or Preferred Skills

Should be familiar with Visual Stuido

css

Should be familiar with graphics programs

Software Tester

Job Description

The Software Tester will try in every way conceivable to break our software. You’ll be asked to produce test cases that exercise every aspect of the web applications we are making. You’ll need to document these test cases such that they meet United States Food and Drug Administration (21 CFR Part 11) and European Medicines Agency standards for validation of software that deals with digital patient records and signatures.

Qualifications and/or Preferred Skills

Should be familiar with Visual Stuido

Should become familiar with 21 CFR Part 11

Should be familiar with writing and executing formal test cases

Should be familiar with some web testing software

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About Us

Suzanne HendrixPresident and CEO

President and CEOSuzanne Hendrix received her Ph.D. in Mathematics from Boston University and has spent the last 29 years as a statistician focusing on clinical trials research in many different indications. She has extensive experience designing clinical trials, writing statistical analysis plans, running analyses, writing statistical reports, interacting with the FDA and preparing manuscripts for publication. She is experienced at communicating statistical concepts in an understandable way, and has helped develop software for graphically understanding large complex datasets. For the past 8 years, she has focused on statistical issues in Alzheimer's disease such as identifying appropriate outcomes, addressing measurement issues, demonstrating disease modification and optimizing clinical trial design. She has interacted with the division of Neurology products at the FDA and with the EMEA through scientific advice regarding these issues. She is currently an independent consultant in the pharmaceutical industry, primarily supporting clinical trial design and optimization in neurological indications, particularly Alzheimer's disease. She has researched methods for discerning disease modification of a treatment, and has proposed novel approaches to this problem.

Noel EllisonDirector, Statistics and Data Management

Director, Statistics and Data Management
Noel received her Masters in Statistics from Brigham Young University in 2012, and has worked in the pharmaceutical industry for 7 years.

She works with Suzanne Hendrix focusing on statistical issues in Alzheimer's disease such as identifying appropriate outcomes, addressing measurement issues, demonstrating disease modification and optimizing clinical trial design and analysis.

Kent HendrixDirector, Statistical Programming

Director, Statistical Programming
Kent has worked in the Pharmaceutical industry doing all aspects of statistical programming in SAS for 28 years.
He has worked on 6 NDAs and managed groups of SAS programmers.
He taught SAS programming at Brigham Young University, and AP Statistics and Computer Science at the High School Level.
He developed a SAS program Log file analysis tool that helps SAS programmers debug their code faster.
He developed a web based clinical trial management software that handles the enrollment and randomization of subjects, drug distribution to sites, and allocation to subjects.
It has managed global phase 1, 2, and 3 clinical trials.
He holds a 10th degree black belt in Bushikai Kishindo Martial Arts. www.kishindo.com
He would like to some day retire back to teaching High School. He found that to be very rewarding. He only taught for 2 years, but in those two years, he gained some life-long friends.